eCOA & RTSM Application Specialist

This is a fully remote position, open to applicants in Poland.

📋 Description

• Provide support for the design, deployment, configuration, and management of eCOA solutions, including ePRO and eConsent, and RTSM across international clinical trials.

• Serve as a subject matter expert for eCOA and RTSM during the phases of study initiation, maintenance, and closure.

• Establish functional requirements and engage in solution design and configuration.

• Create and uphold system specifications, user requirements, edit checks, notifications, and reporting criteria.

• Assist in the design of Case Report Forms related to eCOA.

• Develop UAT test scripts and coordinate or conduct system validation testing.

• Validate eCOA logic, rules, and study calculations in accordance with protocol requirements.

• Aid in CDISC-compliant data mapping and work alongside Clinical Data Standards teams.

• Contribute to data cleaning strategies and examine data management plans and edit check specifications.

• Prepare training materials specific to the study and assist in the delivery of training sessions.

• Lead or take part in internal and sponsor meetings regarding system setup, changes, and issue resolution.

• Document system configuration and file eCOA and RTSM deliverables in the Trial Master File.

• Manage updates, amendments, and change requests throughout the lifecycle of the study.

• Troubleshoot issues, escalate risks, and ensure prompt resolution with vendors and project teams.

• Ensure adherence to ICH-GCP, FDA, EMA, and other pertinent regulatory standards.

• Contribute to the creation of SOPs, work instructions, process improvement initiatives, templates, and eCOA/RTSM standards.

• Promote continuous improvement, training, and knowledge sharing within Clinical Data Management.

• Stay updated on the latest eCOA and RTSM technologies, regulatory developments, and best practices.

• Assist in vendor evaluation, standardization, and relationship management when necessary.

• Act as a resource for cross-functional teams regarding eCOA and RTSM processes, timelines, and risks.

• Take on additional responsibilities as assigned when qualified, experienced, or adequately trained.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Computer Science, Health Sciences, or a related discipline.

• 3–5 years of experience with eCOA, EDC, IRT, or eClinical solutions in a CRO, pharmaceutical, or health-technology environment.

• Strong understanding of eCOA systems and patient-reported outcomes (ePRO).

• Comprehensive knowledge of clinical trial processes and data management principles; familiarity with CDISC is advantageous.

• Experience in system configuration, UAT, edit checks, and validation processes.

• Proven ability to collaborate in cross-functional environments and manage multiple priorities.

• Analytical mindset coupled with robust problem-solving abilities.

• Excellent verbal and written communication skills.

• Experience with global trials and understanding of regulatory expectations, including those from FDA, EMA, GDPR, and HIPAA.

• Strong focus on quality and data integrity.

• Technically curious with a digital mindset.

• Awareness of problem-solving and escalation processes.

• Effective stakeholder communication and collaboration skills.

• Strong organizational skills, accountability, and ability to work autonomously.

• Good knowledge of good clinical practices and relevant Health Canada and FDA regulations/guidelines.

• Must possess legal authorization to work in Poland.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Attractive prospects for career advancement.

• Equal opportunity and recruitment accommodations for applicants with disabilities, upon request.